Tobacco Substitute

ABSTRACT

The present disclosure provides a smokeless tobacco substitute which may reduce and/or alleviate many of the health problems associated with the use of cigarettes and conventional smokeless tobacco products. Further, methods of manufacturing and packaging the smokeless tobacco substitute are also disclosed. Finally a method of using the smokeless tobacco substitute to assist a user in reducing or ceasing the use of cigarettes and conventional smokeless tobacco products is also disclosed.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to a tobacco substitute. More specifically, the present disclosure relates to a smokeless tobacco substitute, uses thereof and methods of manufacturing the same.

BACKGROUND

The U.S. Surgeon General has determined that cigarette smoking is a major risk factor in coronary heart disease and is the cause of approximately 30% of all cancer deaths. Smokeless tobacco products also lead to health problems for those consuming them. However, it is very difficult to give up the use of tobacco products, and any cessation therapy has to deal with both the physiological and the psychological dependence on the tobacco product and nicotine. To date, the best results have been obtained with nicotine chewing gum, which achieves direct delivery to the systemic circulation by buccal absorption. However, chewing gum formulations taste bad, may lead to mouth ulcers and heartburn, cannot be used effectively by denture wearers, and depend entirely on the patient following the prescribed chewing regime.

As with other addictions, addiction to nicotine encompasses two key components. One component is a physiological addiction to nicotine itself. The physiological addiction is mediated through adaptive changes in specific brain nicotinic acetylcholine receptors that lead to typical withdrawal symptoms upon abstaining from nicotine. A second component is a complex behavioral component. The behavior component is linked to learned internal cues associated with various positive or negative emotional feelings tied to tobacco use or abstinence.

The physiological addiction to nicotine is significant. The American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (third edition, revised) lists the officially recognized diagnostic criteria for nicotine withdrawal as the presence of at least four of the following signs: craving for nicotine, irritability, frustration, anger, anxiety, difficulty concentrating, restlessness, decreased heart rate and increased appetite or weight gain.

In order to minimize the risk associated with cigarette use and the restriction on the use of cigarettes in public areas, many smokers are turning from traditional cigarettes to smokeless tobacco products. Smokeless tobacco products are generally recognized to be a safer alternative to smoking. However, the use of smokeless tobacco products also carry certain risks as discussed herein. In response to the foregoing, tobacco companies have increased the marketing for smokeless tobacco products.

Data from the US Centers for Disease Control and Prevention (CDC) showed that among adults aged 18 and older in 2004, about 3% of people (6% of men and less than 1% of women) were current users of smokeless tobacco. Rates among young people, however, are higher. According to the CDC's 2005 survey, about 14% of male high school students and 2% of female high school students were using smokeless tobacco. The CDC 2004 Tobacco Survey reported that, of middle school students, 4% of the boys and 2% of the girls reported using smokeless tobacco at least once in the 30 days before the survey. Teens that use smokeless tobacco are more likely to smoke later. Therefore, the use of smokeless tobacco products is on the rise.

Numerous smokeless tobacco products are commonly available today. Examples include (i) loose oral snuff, where the user picks a snuff dose by his/her fingers from an open package, (ii) pouches containing loose oral snuff, (iii) chewing tobacco, (iv) snus (a form of moist snuff) and (v) tobacco lozenges. The use of smokeless tobacco in general parlance is loosely referred to as “chewing,” although the term “dipping” is particularly associated with the use of snuff. The use of smokeless tobacco entails the placing of a wad of leaf tobacco or a pinch of snuff in the gingival buccal area of the mouth cavity and sucking on the “quid”. The term “quid” is given to a portion of smokeless tobacco which is held in the mouth for chewing or dipping. Many persons chew or dip during most waking hours, and some persons keep a quid in place for 24 hours a day.

For many years, it has been demonstrated that tobacco use is harmful, including tobacco exposure through the use of smokeless tobacco. Cured tobacco is known to contain a number of nitrosamines, including the harmful carcinogens N′-nitrosonornicotine (NNN) and 4-(N-nitrosomethylamino)-1-(3-pyridyl)-1-butanone (NNK). The use of smokeless tobacco is also associated with other deleterious effects on the body, e.g., the skin, teeth. Among the health problems that have been identified with the use of smokeless tobacco are: (i) oral (mouth) cancer, (ii) pancreatic cancer, (iii) addiction to nicotine, (iv) leukoplakia (white sores in the mouth that can lead to cancer), (v) receding gums (gums slowly shrink away from around the teeth), (vi) bone loss around the roots of the teeth, (vii) abrasion (scratching and wearing down) of teeth, (viii) staining of teeth and (ix) bad breath.

Smokeless tobacco may also play a role in heart disease and high blood pressure. Men who switched from cigarettes to snuff or chewing tobacco in a large American Cancer Society study had higher death rates from heart disease, stroke, cancer of the mouth and lung, and all causes of death combined than fowler smokers who stopped using all tobacco products.

Therefore, the use of smokeless tobacco products is not a risk-free substitute for smoking. However, despite the knowledge of the potential harm from tobacco products, individuals continue to use tobacco products and many become addicted to these products.

It is therefore desirable to provide a smokeless tobacco substitute which does not cause the deleterious health problems enumerated herein for use as a substitute for cigarettes and smokeless tobacco and a method of making the same. It is furthermore desirable to provide such a substitutionary product which simulates the appearance, texture, tactile response, and mode of use of genuine smokeless tobacco. Other objects and uses of the present disclosure and methods herein are obvious to those skilled in the art.

BRIEF DESCRIPTION OF DRAWINGS

It should be noted that identical features in different drawings are shown with the same reference numeral.

FIG. 1 shows a top view of one embodiment of the smokeless tobacco substitute.

FIGS. 2 a-2 d show cross sectional views of exemplary configurations of the smokeless tobacco substitute. FIG. 2 a shows an embodiment comprising a single portion of material; FIG. 2 b shows an embodiment having an outer portion and an inner portion; FIG. 2 c shows an embodiment having an outer portion and three inner portions; FIG. 2 d shows an embodiment having an outer portion and an inner portion comprised of different materials.

FIG. 3 shows a cross sectional view of an exemplary configurations of the smokeless tobacco substitute. FIG. 3 shows an embodiment comprising a hollow outer portion containing a non-liquid component.

FIG. 4 shows one embodiment of the placement of the smokeless tobacco substitute placed in a user's mouth.

DETAILED DESCRIPTION

The present disclosure provides a tobacco substitute which may reduce and/or alleviate many of the health problems associated with the use of cigarettes and conventional smokeless tobacco products. Further, methods of manufacturing and packaging the tobacco substitute are also disclosed. Finally a method of using the tobacco substitute to assist a user in reducing or ceasing the use of cigarettes and conventional smokeless tobacco products is also disclosed.

Tobacco Substitute Device One embodiment, of the tobacco substitute of the current disclosure is demonstrated generally in FIG. 1. In a specific embodiment, the tobacco substitute is a smokeless tobacco substitute. With reference to FIG. 1, a smokeless tobacco substitute 10 has been developed comprising a compositional material that is capable of absorbing one or more liquid components, retaining all or a portion of said liquid(s) for a period of time, and releasing all or a portion of said liquid(s) at a desired time and/or rate. Such release may be a controlled release as described herein.

In one embodiment, the smokeless tobacco substitute contains one or more constituents present in a tobacco product; this embodiment may be referred to as a harm reduction device when the concentration of one or more constituents of a tobacco product that are known to cause harm are reduced as compared to a tobacco product. In another embodiment, the smokeless tobacco substitute may lack the components of a tobacco product other than the presence of nicotine, a nicotine substitute, flavoring components and/or other constituents that that are generally recognized in the art as safe for consumption by a user; in a specific embodiment, the smokeless tobacco substitute may lack the constituents of the tobacco plant other than the presence of nicotine.

In one embodiment of the present disclosure, the smokeless tobacco substitute is designed to appear similar to a pouch tobacco product (one example of a pouch tobacco product is a Skoal Bandit). In such an embodiment (illustrated in FIG. 1), the smokeless tobacco substitute 10 may be a substantially rectangular pouch familiar to users of smokeless tobacco. In this particular embodiment, the smokeless tobacco substitute 10 includes a pair of long sides 12 and short sides 14 thereby forming the substantially rectangular shape. The long 12 and/or short sides 14 may be modified to simulate certain characteristics of commercially available pouch products. For example, the smokeless tobacco substitute may be modified to comprise crimps or similar structures (designated as 16) such as may be formed as a result of the normal manufacturing process for the commercially available pouch product. Structures 16 may be present on the long 12 and/or short 14 sides. Furthermore, the smokeless tobacco substitute may be contained, either partially or entirely, within a porous covering similar to commercially available pouch tobacco products. The covering may also contain crimps or similar structures (as described above) such as may be formed as a result of the normal manufacturing process for the commercially available pouch product. In an alternate embodiment, the smokeless tobacco substitute 10 is designed to appear similar to a snus product.

In addition, the smokeless tobacco substitute 10 may be manufactured to resemble other articles that may commonly be placed in the mouth of a user, such as a piece of gum (for example, a breath freshening gum such as but not limited to, Eclipse brand gum having a square or rectangular configuration) or a mint having a cylindrical configuration with a generally oval cross section. Other shapes and configurations are also possible as the materials from which the smokeless tobacco substitute 10 is manufactured are pliable or can be manufactured into desired shapes and configurations. In one embodiment, the goal of the present disclosure is to provide the smokeless tobacco substitute 10 in a form that is familiar to the public so as to allow a user of the smokeless tobacco substitute 10 to use the device without attracting attention that may occur when a tobacco product is used.

In the foregoing embodiments, such structures may be formed by any method, including without limitation, casting, molding, form molding, mechanical crimping and/or heat assisted crimping; other techniques as is known in the art for the materials described herein may also be used. The dimensions may be selected to provide a comfortable placement in the mouth of a user.

In an alternate embodiment, the smokeless tobacco substitute 10 may have other configurations that do not resemble or mimic commercially available products. In such embodiments, the smokeless tobacco substitute 10 may have a cylindrical, circular or polygonal (pentagon, hexagon etc.) cross section. Other cross sectional shapes may also be used. In a particular embodiment, the shape of the smokeless tobacco substitute is designed to conform to the contours of a user's oral cavity.

The smokeless tobacco substitute 10 may be manufactured from a variety of materials. Materials suitable for this purpose include, but are not limited to, cellulose esters such as cellulose acetate (including triacetate and diacetate forms), a porous plastic, polyamides such as a nylon (including but not limited to nylon 66 or nylon 6), polypropylene, polyethylene, polyolefins and cellulose ethers. Combinations of the foregoing may also be used. In one embodiment, the smokeless tobacco substitute 10 is manufactured from cellulose acetate. In another embodiment, the smokeless tobacco substitute is manufactured from a porous plastic material described in U.S. Pat. Nos. 6,541,055 and 6,024,012, which are herein incorporated by reference for such teaching. In still a further embodiment, the smokeless tobacco substitute is manufactured from a combination of cellulose acetate and porous plastic material.

The smokeless tobacco substitute 10 may be manufactured from a single material having uniform properties, such as but not limited to, the rate of liquid release when the smokeless tobacco substitute 10 is placed in the mouth of a user. In one embodiment, the rate of liquid release is determined, at least in part, by the porosity of the material from which the smokeless tobacco substitute 10 is manufactured. In such an embodiment, the smokeless tobacco substitute 10 may comprise a variety of configurations. In one embodiment, the smokeless tobacco substitute 10 comprises a portion 20 (illustrated in FIG. 2A). The portion 20 may have a cavity 22 if desired. The cavity 22, when present, may be empty or may contain an additional ingredient or ingredients; the additional ingredients may be in the form of a non-liquid component as described herein. The cavity 22 may extend completely or partially along a dimension of the portion 20. In one embodiment, the ingredient(s) are at least one of those ingredients discussed herein, including flavoring components. The cavity may also serve as a conduit to increase the flow of saliva from the users mouth to the smokeless tobacco substitute 10 to favor release of the at least one liquid component. The cavity 22 may also speed loading of the liquid component into the smokeless tobacco substitute 10 (as discussed herein).

In an alternate embodiment (illustrated in FIG. 2B), the smokeless tobacco substitute 10 comprises an outer portion and one or more inner portions. In FIG. 2B, the smokeless tobacco substitute 10 is shown comprising an outer portion 24 and a single inner portion 26. The outer and inner portions may be used to absorb a distinct liquid component or may absorb the same liquid component. For example, the outer component may contain a mix of flavoring agents (as discussed herein) and the one or more inner portions may contain nicotine, a nicotine substitute or a Nicotiana extract. As shown in FIG. 2B, the inner component 26 may have a cavity 22, for the purposes discussed above. As shown in FIG. 2C, the smokeless tobacco substitute 10 may comprise more than one inner portion. In FIG. 2C, three inner portions (32 a-c) are shown surrounded by an outer portion 30; more or fewer inner portions may be present as desired. One or more of the inner portions 32 a-c or the outer portion 30 may contain a cavity, designated 34 and 36, respectively, for the purposes discussed above.

Alternatively, the smokeless tobacco substitute 10 may be manufactured from a single material differing in at least one property, or more than one material differing in at least one property. The differing property may be the rate of liquid release when the smokeless tobacco substitute 10 is placed in the mouth of a user. In this embodiment, the smokeless tobacco substitute 10 may comprise an outer portion and one or more inner portions as shown in FIGS. 2B and 2C. In another embodiment, the smokeless tobacco substitute 10 may comprise an outer portion of a first material and an inner portion of a second material. The first and second material may differ in at least one property, such as the rate of liquid release when the smokeless tobacco substitute 10 is placed in the mouth of a user. Such an embodiment is illustrated in FIG. 2D. FIG. 2D shows the outer portion 40 manufactured from a first material surrounding, at least partially, an inner portion 42 manufactured from a second material. In a specific embodiment, the outer portion is cellulose acetate and the inner portion is a porous plastic material as described above.

In still a further embodiment, when the smokeless tobacco substitute 10 contains one or more cavities as described, the cavity may contain a non-liquid component. The non-liquid component may be in the form of a powder, paste or slurry or may be in the form of a dry or wet material. The non-liuid component may be contained within the smokeless tobacco substitute 10, such as by inclusion in a porous membrane or pouch. In one embodiment, the material is a finely divided tobacco material. The tobacco material may be generated from tobacco leaves as is known in the art and may be flavored as is known in the art. In such an embodiment, the outer portion may be manufactured from the materials discussed herein. In one embodiment, the outer material is cellulose acetate. In such an embodiment, the outer portion may contain one or more of the liquid components described herein. Such a liquid component may contain additional flavoring agents, additional nicotine or a nicotine substitute or other agents as described herein. In such an embodiment, the addition of the agents described above may allow the lowering of the tobacco content of the device, while still providing the user the cessation of a tobacco product.

FIG. 3 provides an exemplary embodiment. In FIG. 3, the outer portion is designated 50 and surrounds a non-liquid component 52. As stated above, the non-liquid component may be a finely divided tobacco product. In such an embodiment, the smokeless tobacco substitute would provide the user with the sensation of a tobacco product, with the added benefits of additional flavoring or other agents described herein and be a safer alternative to commercially available tobacco products.

In such embodiments, each of the inner and/or outer portions may contain the same liquid component or a different liquid component. The rate of liquid release may be selected such that when at least one of the inner or outer portions contain different liquid components, the rate of release of such liquid components may be varied. In one embodiment, the density of the material comprising the inner and/or outer portions is varied to impact the rate of liquid release. For example, the smokeless tobacco substitute 10 may have an outer portion of cellulose acetate having a Dpf of 200 and an inner portion of cellulose acetate having a Dpf of 5. In this embodiment, the rate of liquid release would be greater from the outer portion than the inner portion. In a particular embodiment, the inner portions are selected to have a slower rate of liquid release to provide a longer lasting impact to the user.

In the embodiments described above, when the outer and inner portions absorb a different liquid component, they may absorb the liquid component separately and then be assembled together as shown. In an alternate embodiment, a part of the inner or outer portion may extend beyond the other and allow for preferential uptake of a desired liquid component. As would be known in the art, when the outer and inner portions absorb distinct liquid components, some intermingling of the components may occur during loading or during storage of the device 10.

In one embodiment, the material(s) comprising the smokeless tobacco substitute 10 is cellulose acetate and has a denier per filament (Dpf) value of between about 1 and about 1,000, between about 100 and about 500, between about 500 and about 1000, between about 250 and about 750, between about 100 and about 250, between about 50 and about 100 or between about 1 and about 100. In embodiments where the smokeless tobacco substitute 10 is manufactured from a porous plastic material, the rate of liquid release may be determined by the size of the pores contained in the porous plastic material. In one embodiment, the pores are from about 2 to about 500 microns, from about 5 to 400 microns or about 10 to 100 microns.

The embodiments discussed above can be designed or modified to appear similar to a pouch tobacco product as discussed above.

The material from which the smokeless tobacco substitute 10 is manufactured may be selected on the basis of the rate of liquid release when the smokeless tobacco substitute 10 is placed in the mouth of a user, the amount of liquid capable of being absorbed by the material, the ability of the material to conform to the contours of the mouth of the user, the feel of the material when placed in the mouth of the user or a combination of the foregoing.

The smokeless tobacco substitute 10 absorbs at least one liquid component and retains at least a portion of the liquid component and releases at least a portion of the liquid component at a desired time and/or rate. Therefore, the smokeless tobacco substitute 10 is provided as a wet product. A wet product is defined as a product containing at least 30% moisture content. In contrast, most of the pouch smokeless containing products currently available are provided as dry products, with a moisture content less than 15%. The lack of moisture in commercially available pouch smokeless tobacco products leads to a drying out of the product during storage while awaiting sale to a user, making the product unsuitable for use. This disadvantage is not present with the smokeless tobacco substitute 10 of the present disclosure since the device will retain the moisture during storage.

A variety of liquid components may be used in conjunction with the smokeless tobacco substitute 10 of the present disclosure. In one embodiment, the liquid component is designed to mimic the flavor of a tobacco product, such as a smokeless tobacco product.

In one embodiment, the liquid component lacks the constituents present in a tobacco plant, except possibly nicotine. In another embodiment, the liquid component lack the components of a tobacco product other than the presence of nicotine, a nicotine substitute, flavoring components and/or other constituents that that are generally recognized in the art as safe for consumption by a user. In such embodiments, the liquid component may be designed to mimic the flavor of a tobacco product, such as a smokeless tobacco product. In a specific embodiment, such a liquid component contains nicotine and/or a nicotine substitute. The term “nicotine substitute” refers to a compound capable of binding a receptor to which nicotine binds in the human body, such as the nicotinic acetylcholine receptor. A nicotine substitute as used herein does not include nicotine. Examples of such nicotine substitutes include, but are not limited to, metabolites of nicotine in the subject (such as but not limited to continine) lobeline, arecoline, isoarecolone, anabasine, cytosine, bupropion, polacrilex and nicotine bitartrate. The foregoing listing of compounds includes the free compounds, salts thereof and analogues thereof that exhibit similar properties.

In one embodiment, the liquid component contains nicotine. In another embodiment, the liquid component contains a nicotine substitute. In an alternate embodiment, the liquid component contains nicotine and a nicotine substitute. In still another embodiment, the liquid component contains neither nicotine nor a nicotine substitute.

In an alternate embodiment, the liquid component contains a liquid tobacco extract extracted from the leaves, flowers, roots, stems or a combination thereof of any member of the genus Nicotiana. Exemplary species include N. rustica and N. tabacum (including but not limited to varieties and/or cultivars designated LA B21, LN KY171, TI 1406, Basma, Galpao, Perique, Beinhart 1000-1, and Petico). Other species include N. acaulis, N. acuminata, N. acuminata var. multiflora, N. africana, N. alata, N. amplexicaulis, N. arentsii, N. attenuata, N. benavidesii, N. benthamiana, N. bigelovii, N. bonariensis, N. cavicola, N. clevelandii, N. cordifolia, N. corymbosa, N. debneyi, N. excelsior, N. forgetiana, N. fragrans, N. glauca, N. glutinosa, N. goodspeedii, N. gossei, N. hybrid, N. ingulba, N. kawakamii, N. knightiana, N. langsdorffii, N. linearis, N. longiflora, N. maritima, N. megalosiphon, N. miersii, N. noctiflora, N. nudicaulis, N. obtusifolia, N. occidentalis, N. occidentalis subsp. hesperis, N. otophora, N. paniculata, N. pauciflora, N. petunioides, N. plumbaginifolia, N. quadrivalvis, N. raimondii, N. repanda, N. rosulata, N. rosulata subsp. ingulba, N. rotundifolia, N. setchellii, N. simulans, N. solanifolia, N. spegazzinii, N. stocktonii, N. suaveolens, N. sylvestris, N. thyrsiflora, N. tomentosa, N. tomentosiformis, N. trigonophylla, N. umbratica, N. undulata, N. velutina, N. wigandioides, and N x sanderae.

The extracts may be prepared by any method known to those skilled in the art, including without limitation: (i) leaves, flowers, roots, stems or a combination thereof, (ii) grinding the leaves, flowers, roots, stems or a combination thereof, reconstituting the ground material in a liquid, such as water, and filtering the solid insoluble parts from the liquid, (iii) heating or boiling the leaves, flowers, roots, stems or a combination thereof in a liquid, such as water and/or (iv) performing a chemical extraction on the leaves, flowers, roots, stems or a combination thereof. Combinations of the forgoing may also be used.

The extracts may be processed to reduce the level of harmful components in the tobacco; alternatively, the tobacco starting material may be treated to reduce the level of harmful components in the tobacco. Furthermore, the extracts may be processed to remove one or more components of the tobacco extract that are known to cause harm. In certain embodiment, the processing step may be carried out to reduce or eliminate levels of nicotine in the extract. When the levels of naturally occurring nicotine are reduced or eliminated, nicotine or a nicotine substitute may be added to the liquid component. The liquid component may also be modified by adding nicotine or a nicotine substitute.

The use of the smokeless tobacco substitute containing such a liquid component provides a safer alternative to the use of commercially available tobacco products as the amount of actual tobacco constituents is reduced as compared to products containing un-extracted tobacco.

In any of the foregoing embodiments, the liquid component may contain varying levels of nicotine or a nicotine substitute. For example, the liquid component may be a liquid tobacco extract as described above. In these embodiments, the levels of naturally occurring nicotine in the liquid tobacco extract may reduced or eliminated if desired. The levels of nicotine may be assayed in the extracted liquid component prior to addition of nicotine or a nicotine substitute. In another example, the liquid component may contain no liquid tobacco extract and the levels of nicotine and/or a nicotine substitute may be adjusted as desired.

In these embodiments, the amount or concentration of nicotine and/or nicotine substitute may start at a first level and be reduced in a gradient or step-wise manner in a series of available smokeless tobacco substitutes 10. For example, one embodiment of the smokeless tobacco substitute 10 may contain approximately 8-12 mg of nicotine and/or nicotine substitute per device. Another embodiment may contain approximately 4-8 mg of nicotine and/or nicotine substitute per device. A further embodiment may contain approximately 1-4 mg of nicotine and/or nicotine substitute per device. Yet another embodiment may contain approximately 0 mg of nicotine and/or nicotine substitute per device. A user, may begin by consuming the smokeless tobacco substitute 10 with the largest amount of nicotine and gradually reduce their addiction to and/or craving for nicotine by using smokeless tobacco substitute 10 with decreasing amounts or concentrations of nicotine. Eventually, the user may select a smokeless tobacco substitute 10 with no nicotine or nicotine substitute. As such, the smokeless tobacco substitute may be used as a cessation product.

In any of the foregoing embodiments, the liquid component(s) may also be supplemented with other agents as desired, regardless of whether the liquid component contains tobacco extracts or nicotine or nicotine substitutes. Any vitamin, herb or chemical can be added to provide additional benefits. Medicaments and other drugs that are delivered orally may also be added. In certain cases, the smokeless tobacco substitute 10 may be used to specifically deliver a medicament or drug to a patient that has difficulty taking such medications in their traditional form. In this aspect, the delivery of the medicament or other drug may be coincident with the delivery of a flavoring component, a nicotine or nicotine substitute component, a combination of the foregoing or may be delivered alone. Some exemplary ones include anti-oxidants such as vitamin C (ascorbic acid), A and D. Also caffeine or derivatives such as guarana may be added. Other stimulants can also be added such as ginsing, guto kola or ginko biloba. Herbal components may be added to enhance certain organoleptic qualities and/or provide certain physiological effects. The additional non-essential ingredients may be classified as antiseptics, demulcents, diuretics, emollients, stimulants, tonics, rubefacients, sialagogues, hemostatics, vulneraries, or combinations thereof. Non-essential ingredients with pain relieving, anti-inflammatory and antihistamine active ingredients can also be utilized. For example, the non-essential ingredients of the herbal component may comprise extracts of: red clover, Echinacea, ginger, rose hips, white clover, sweet clover, licorice, ginseng, guarana, anise, clove, as well as any other suitable leaf, root, or gum (e.g., gum tragacanth, gum arabic, gum acacia, and/or gum karaya), and any combination thereof. Since every herb contains biochemical constituents that can have an effect on the body, the potential additional non-essential ingredients for the herbal component are limited only by the desired overall organoleptic qualities and physiological effects of the smokeless tobacco substitute.

In any of the foregoing embodiments, the liquid component(s) may be flavored to mimic a desired taste, such as the taste of a smokeless tobacco product or the taste of tobacco. Such flavoring can be accomplished through the following non-limiting additions: essential oils, natural and artificial flavors, sweeteners (sugar, molasses, caramel color, sucralose or other artificial sweeteners), extracts of plant products, including but not limited to, mint leaves (peppermint, spearmint, wintergreen), lemon peel, cinnamon, anise, licorice, ginger, cloves, coffee, tea leaves, cayenne, tabasco or other peppers. The nature and/or concentration of the additives may be dependent on the flavors to be mimicked. For example, in one embodiment where the smokeless tobacco substitute is flavored to mimic a wintergreen flavor, a cinnamon flavor or a citrus flavor.

Referring to FIG. 4, the smokeless tobacco substitute 10 may be inserted into the mouth between the gum and lip area. Referring to FIG. 4, when the smokeless tobacco substitute 10 is exposed to the user's saliva, the smokeless tobacco substitute 10 will release at least a portion of its liquid contents so that liquid component is introduced into the user's saliva. Accordingly, the liquid component may mix with the saliva and subsequently be ingested or absorbed into the bloodstream by the user.

In one embodiment, the release of the liquid component is a controlled release. “Controlled release” as used herein means the release of at least a portion of one or more liquids from the smokeless tobacco substitute 10 in a manner that is modified from an immediate release composition. The modified release may be a differential release, a sustained/prolonged/slow release, a slow release, a triggered release or a combination of the foregoing. In one embodiment, the controlled release is a sustained/prolonged/slow release. In a specific embodiment, the sustained/prolonged/slow release is a release of at least a portion of the previously absorbed liquid component(s) contained in the smokeless tobacco substituteat a desired rate that is prolonged over time. In one embodiment, the smokeless tobacco substitute 10 may degrade over a period of time as it releases its liquid contents. In one embodiment, the controlled release may be the triggered release of at least a portion of the previously absorbed liquid component(s) contained in the smokeless tobacco substitute. In a particular embodiment, the triggered release occurs upon contact with human saliva after placement inside a user's mouth. In one embodiment, the controlled release is a differential release. In a particular embodiment, the differential release is a release of at least a portion of the previously absorbed liquid component(s) contained in the smokeless tobacco substitute that occurs at different rates to provide a long-lasting release of such liquid component(s) from the smokeless tobacco substitute or the release of different liquid components at different rates. Methods for modifying release rates are discussed herein. Combinations of the foregoing may also be used.

Although various ingredients have been described above as part of a composition according to the present invention, these ingredients are merely exemplary and not limiting of that which ingredients may be used within the device of the present disclosure.

Method of Manufacture

Loose snuff is also packaged by weight in a small can and sealed for freshness. The method of use differs between the two forms of snuff. When a can of loose snuff is purchased the seal on the can is broken, and the lid is removed. The user then inserts the forefinger and thumb into the can and extracts a “pinch” of snuff, and pack's the loose snuff into the lower gum and lip area of the mouth. With this method of consumption the loose snuff has a tendency to float throughout the oral cavity. When a can of snuff is purchased that is filled with portion pouches the user breaks the seal on the can, removes the lid and simply removes one of the pouches of snuff and inserts the pouch in-between the lower lip and gum area of the mouth. Because the loose snuff is contained in the sealed paper pouch the problem of loose snuff floating throughout the oral cavity is eliminated.

Because of its consistency, snuff is relatively difficult to package in filled portions, and in order to enable snuff to pass freely down a storage chute or like device into the portioning pockets, it is normal to work with snuff having a moisture content of less than 30%. Snuff which is ready for consumption should have ideally a moisture content of 50-55%, which means that it must be moistened subsequent to being packeted. As a result hereof, the total manufacturing process takes a relatively long time to complete, and requires a significant amount of machinery.

Also contemplated within the scope of this disclosure is a method of manufacturing and packaging using the smokeless tobacco substitute 10.

In one embodiment, a desired volume of liquid (the liquid component) is dispensed into a receiving canister and a number of smokeless tobacco substitutes 10 sufficient to absorb said liquid are subsequently added to the canister. Over a period of time, the smokeless tobacco substitutes 10 will absorb essentially all of the liquid and retain said liquid. By “essentially all” it is meant that at least 90% of the liquid added in one embodiment, or 95%, 98%, 99.0% or 99.9% of the liquid added in other embodiments will be absorbed. Upon being placed in the mouth of the user, the smokeless tobacco substitute 10 will release the absorbed liquid component as described herein.

The desired volume of liquid may be calculated by determining the maximum volume of liquid that can be absorbed by a single smokeless tobacco substitute and multiplying that volume by the number of smokeless tobacco substitutes to be added to the canister.

In another embodiment, a desired number of the smokeless tobacco smokeless tobacco substitutes 10 are placed into the receiving canister before an appropriate amount of liquid is added. Over a period of time, the smokeless tobacco smokeless tobacco substitutes 10 will absorb essentially all of the liquid and retain said liquid. By “essentially all” it is meant that at least 90% of the liquid added in one embodiment, or 95%, 98%, 99.0% or 99.9% of the liquid added in other embodiments will be absorbed. Upon being placed in the mouth of the user, the smokeless tobacco substitute 10 will release the absorbed liquid component as described herein In yet another embodiment, a desired number of the smokeless tobacco substitutes 10 are placed (i.e., submerged either partially or wholly, or dipped) into a liquid for a period of time sufficient to allow the smokeless tobacco substitutes 10 to absorb a sufficient volume. The smokeless tobacco substitute will retain at least a portion of said liquid. Upon being placed in the mouth of the user, the smokeless tobacco substitute 10 will release the absorbed liquid component as described hereinThe liquids discussed herein may be used in the production methods discussed above.

Method of Use

It is well known that tobacco, and tobacco products, including smokeless tobacco, contain numerous compounds deleterious to one's health. For example, cured tobacco is known to contain a number of nitrosamines, including the harmful carcinogens N′-nitrosonornicotine (NNN) and 4- (N-nitrosomethylamino)-1-(3-pyridyl)-1-butanone (NNK). The use of smokeless tobacco is also associated with other deleterious effects on the body, e.g., skin, teeth, etc. Among the health problems that have been identified with the use of smokeless tobacco are: (i) oral (mouth) cancer, (ii) pancreatic cancer, (iii) addiction to nicotine, (iv) leukoplakia (white sores in the mouth that can lead to cancer), (v) receding gums (gums slowly shrink away from around the teeth), (vi) bone loss around the roots of the teeth, (vii) abrasion (scratching and wearing down) of teeth, (viii) staining of teeth and (ix) bad breath. Cigarette smoke is known to contain several harmful compounds including: (i) cyanide, (ii) benzene, (iii) formaldehyde, (iv) methanol, (v) acetylene and (vi) ammonia. Accordingly, it is desirable to have products that will assist users in ceasing, quitting or reducing their use of and dependence on tobacco products, including smokeless tobacco.

Included within such an embodiment is a liquid component that contains varying levels of nicotine or a nicotine substitute. In this embodiment, the amount or concentration of nicotine may start at a first level and be reduced in a gradient or step-wise manner in a series of available smokeless tobacco substitutes 10. For example, one embodiment of the smokeless substitute 10 may contain approximately 8-12 mg of nicotine and/or nicotine substitute per device. Another embodiment may contain approximately 4-8 mg of nicotine and/or nicotine substitute per device. A further embodiment may contain approximately 1-4 mg of nicotine and/or nicotine substitute per device. Yet another embodiment may contain approximately 0 mg of nicotine and/or nicotine substitute per device. A user, may begin by consuming the smokeless tobacco substitute 10 with the largest amount of nicotine and gradually reduce their addiction to and/or craving for nicotine by using smokeless tobacco substitutes 10 with decreasing amounts or concentrations of nicotine. As such, the smokeless tobacco substitute may be used as a cessation product.

As discussed above, the liquid component may be modified to contain additional agents as described herein.

Addiction to smokeless tobacco has a substantial psychological component to it, including: (i) stimulation, (ii) tension reduction. (iii) pleasurable relaxation and (iv) habit. Accordingly, it is an aspect of this disclosure that the smokeless tobacco substitutes 10 and the liquid component contained therein simulates tactile response and mode of use of genuine smokeless tobacco thereby satisfying a user's psychological needs.

While the invention has been described with respect to a limited number of embodiments, those skilled in the art, having benefit of this disclosure, will appreciate that other embodiments can be devised which do not depart from the scope of the invention as disclosed here. 

1. A smokeless tobacco substitute device comprising a material capable of absorbing a liquid component, retaining the liquid component and releasing at least a portion the liquid component when placed in a mouth of a user, wherein the liquid component comprises nicotine, a nicotine substitute, a Nicotiana extract, a flavoring or a combination of any of the foregoing. 2-54. (canceled) 